Kornimate/medical-research-clean huggingface dataset:
study of vi-0521 compared to placebo in treatment of obesity in adults

Conditions: Obesity

Summary: the purpose of this study is to evaluate the efficacy and safety of two doses of vi-0521 compared to placebo in treatment of obesity in an adult population with bmi ≥ 35.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) ≥ 35 kg/m2 * informed consent * 70 years of age or less * triglyceride level ≤ 200 mg/dl with treatment of 0 or 1 medications * blood pressure of ≤ 140/90 mmhg with treatment of 0-2 medications for hypertension * fasting blood glucose level of ≤ 110 mg/dl exclusion criteria: * stroke/myocardial infarction (mi)/unstable cardiovascular disease within 6 months * clinically significant renal, hepatic or psychiatric disease * unstable thyroid disease or replacement therapy * nephrolithiasis * obesity of known genetic or endocrine origin * participation in a formal weight loss program or lifestyle intervention * history of glaucoma or intraocular pressure * pregnancy or breastfeeding * alcohol abuse * smoking cessation within previous 3 months or plans to quit smoking during study * eating disorders * cholelithiasis within past 6 months * excluded medications * type 2 diabetes * previous bariatric surgery * history of bipolar disorder or psychosis

Keywords: obesity, morbid obesity
managing pain and symptom burden caused by chemotherapy in people with myeloma or lymphoma

Conditions: Multiple Myeloma; Hodgkin Disease; Non-Hodgkin Lymphoma

Summary: the purpose of this study is to find out whether acupuncture treatments can reduce the need for opioid medication when managing pain caused by chemotherapy. the study will compare the effects of adding acupuncture to usual pain management with those of usual pain management alone, in reducing opioid use by relieving pain. researchers also want to find out more about the effects of acupuncture treatments on other symptoms caused by cancer treatments and quality of life.


Eligibility criteria:
inclusion criteria: * age 18 or older * pathological diagnosis of mm, hd or nhl * scheduled for high dose chemotherapy for auto-hsct in the following month (30 days) * not taking opioids regularly in the week prior to consent (one-time dosing of opioids for a painful procedure is allowed) exclusion criteria: * absolute neutrophil count (anc) of \ 2.0 * acupuncture within two weeks prior to hichemo (to avoid residual effects of acupuncture) * unable to provide informed consent

Keywords: pain management acupuncture 20-264
dynamic anterior stabilization with transsubscapular long head of the biceps

Conditions: Anterior Shoulder Dislocation; Bankart Lesion; Hill Sachs Lesion

Summary: clinical study of patients with a history of traumatic anterior shoulder dislocations to test the hypothesis that the arthroscopic dynamic anterior capsular stabilization technique with trans subscapular long head of the biceps tenodesis produces progressive good clinical and imagiological results.

patients with a history of traumatic anterior shoulder dislocations with documented imagological bankart and hillsachs lesions who meet the eligibility criteria will be enrolled in the study and undergo an arthroscopic dynamic anterior capsular stabilization technique with trans subscapular long head of the biceps tenodesis. all patients will be clinically and radiologically/imagiologically assessed preoperatively and at the 6-months, 12-months and 2-years postoperative evaluations. the range of motion (rom), shoulder abduction strength, constant, rowe and wosi scores will be compared from preoperative to 6 months postoperative; from 6 months postoperative to 12 months postoperative; and from 12 months to 2 years postoperative (paired-samples t-test, two-tailed). all continuous variables will be compared between the group of patients with failures (a failure is defined as a patient who suffers an objective re-dislocation episode during the 2-year follow-up) and the group without failures (mann-whitney u test). all categorical variables and outcome results will be compared between the two groups (fisher's exact test). a significant difference will be defined as p\<0.05.

Eligibility criteria:
inclusion criteria: * bankart lesion and hill sachs lesions on the magnetic resonance imaging * one or more traumatic anterior shoulder dislocation episodes * contact or forced overhead sport or work activity exclusion criteria: * proximal humerus fracture * rotator cuff tear requiring repair

Keywords: transsubscapular long head of the biceps tendon lhbt anterior shoulder dislocation bankart hillsachs arthroscopic anterior dynamic stabilization
multimodal markers of neurodegenerative disorders at presymptomatic stages

Conditions: Neurodegenerative Diseases

Summary: neuroprems is a prospective, monocentric, longitudinal, not relating to a medicinal product for human use, non-randomized, non-controlled research. the study mainly aims to identify longitudinal changes and events in multimodal markers of neurodegeneration and neuroinflammation during the presymptomatic phases of neurodegenerative diseases.


Eligibility criteria:
1. inclusion criteria : 1. for all participants : * male or female * age ≥ 18 years * signed informed consent by the subject * affiliated with a social security system or beneficiary of such a regime * ability to undergo an mri exam with gadobutrol 2. for presymptomatic participants only : * absence of a diagnosis of neurodegenerative disease. and at least one of the criteria : * known carrier or relative of a patient carrying a mutation in a causal or at-risk responsible for a neurodegenerative disease * isolated rem sleep behavioral disorder * radiological isolated syndrome * abnormal brain protein aggregates 3. for controls only : * absence of symptoms or diagnosis of neurodegenerative disease (or criteria corresponding to at risk group) 2. exclusion criteria : * clinical symptoms fulfilling the criteria of a neurodegenerative disease (see table in criteria section) * refusal of blood draw or brain mri * mri contraindication (see criteria section) * known allergy to gadoteric acid * unwillingness to be informed in case of abnormal mri (with a significant medical anomaly) * pregnancy or breastfeeding. for women in fertile age a urine pregnancy test will be performed before the mri. * inability to understand information about the protocol * person deprived of their liberty by judicial or administrative decision * person under legal protection (legal guardianship, tutelage or maintenance of justice) * person without any protection and unable to consent * other medical, neurological, psychiatric, or social conditions that in the investigator's opinion are likely to interfere with study conduct.
respiratory decompensation and model for the triage of covid-19 patients

Conditions: COVID-19; Coronavirus; Mortality; Mechanical Ventilation

Summary: the purpose of this study is to prospectively evaluate a machine learning algorithm for the prediction of outcomes in covid-19 patients.

in a multi-center prospective clinical trial, a machine learning algorithm was deployed at five partner hospitals to analyze live patient data, including blood pressure and creatinine levels, to determine the algorithm's ability to predict covid-19 patient prognosis. the primary endpoint was mechanical ventilation of study subjects within 24 hours after hospital admission separate from a decompensation alert related to oxygen levels.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older * confirmed covid-19 infection through rt-pcr test exclusion criteria: * patients aged less than 18 years
acupuncture for pain management of hemodialysis patients

Conditions: End-stage Renal Disease; Chronic Kidney Disease

Summary: the purpose of this study is to determine the feasibility, effectiveness and safety of acupuncture for pain management in hemodialysis patients.

pain is one of the most common symptoms experienced by end-stage renal disease (esrd) patients, which subsequently debilitates patient's quality of life. although reducing pain is crucial to successful patient care in hemodialysis population, symptoms are often undertreated.conventional pharmacological approaches are limited in dialysis population , given their altered pharmacokinetics and pharmacodynamic profiles and increased potential for adverse reactions. acupuncture has been known to be beneficial in various chronic pain condition. as a non-pharmacologic intervention, it might be valuable for pain management in hemodialysis patients whose analgesic use are limited due to altered pharmacokinetics. however, little is known for the benefits of acupuncture for pain management in dialysis population. this study aims to determine whether acupuncture is a feasible, effective and safe therapeutic intervention for pain management in hemodialysis patients.

Eligibility criteria:
inclusion criteria: * started hemodialysis at least 3 months ago * receiving hemodialysis 3 times a week regularly * equilibrated kt/v ≥ 1.2 * pain occurred at least 3 months ago * mymop2 symptom 1 score ≥ 3 * willingness to participate in this study exclusion criteria: * acute/chronic liver disease * events of life-threatening cardiovascular disease within 6 months * events of life-threatening neurological disorder within 6 months * current/past history of neoplasm (in past 5 years) * hemorrhagic disorder * drug abuse/alcoholism * other infectious disease * history of the use of acupuncture, moxibustion or herbs within 1 month

Keywords: hemodialysis end-stage renal disease pain acupuncture
effect of feldenkrais method on balance in patients with mechanical low back pain

Conditions: Mechanical Low Back Pain

Summary: the goal of this clinical trial is to learn if feldenkrais method affects balance in patients with mechanical low back pain. the main questions it aims to answer is: does feldenkrais method affects balance in patients with mechanical low back pain. participants will: be assessed for inclusion using slump and straight leg raise tests. visit the clinic twice every week for sessions. assessed pre and post treatment using biodex balance.

sample size calculation showed that our sample is 40. forty patients with mechanical low back pain not referring beyond the knee will be recruited from souad kafafi hospital and multiple outpatient clinics in giza, egypt. inclusion criteria is male or female patients, 18-45 years, mechanical pain for the last 6 months, with no previous surgeries or diseases in the spine. treatment strategy include 10 treatment sessions for each allocated subject. core strengthening exercises and feldenkrais method (balance exercises) are the treatment approached used in this study. two experienced physical therapists will apply the treatment in the faculty of physical therapy clinic. overall, mediolateral, and anteroposterior stability will be assessed for each patient. the measurement will be done twice pretreatment and immediately after the last session.

Eligibility criteria:
inclusion criteria: * mechanical back pain. * symptoms lasted for the last 6 months. * not referring beyond the knee. * mild to moderate pain in numerical pain rating scale and mild to moderate disability on oswestry disability index exclusion criteria: * spine surgeries * chronic diseases * accidents and fractures

Keywords: feldenkrais method mechanical low back pain balance
study investigating enbrel treatment for ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: to identify the following problems and questions with respect to the safety and effectiveness of enbrel during the post-marketing period as required by korea food and drug administration (kfda)'s regulations. 1. unknown adverse reactions, especially serious adverse reactions 2. change of the incidences of adverse reactions under the routine drug uses 3. factors that may affect the safety of the drug 4. factors that may affect the effectiveness of the drug


Eligibility criteria:
inclusion criteria: * adults: severe ankylosing spondylitis (as) in patients who do not respond adequately to previous therapy exclusion criteria: * patients with known hypersensitivity to enbrel or any component of the product * patients with sepsis or risk of sepsis * patients with active infections including chronic or localized infections such as tuberculosis.

Keywords: ankylosing spondylitis
triple versus dual antiplatelet therapy in patients undergoing coronary stent implantation

Conditions: Acute Coronary Syndrome

Summary: cilostazol is an kind of oral antiplatelet agent with a rapid onset of action that selectively inhibits phosphodiesterase iii, a mechanism different from adenosine diphosphate (adp) receptor antagonists. previous studies had suggested that cilostazol has lipid-modifying and vasodilating effects in addition to antiplatelet effects. from those experimental and clinical backgrounds, we assumed that triple antiplatelet therapy with aspirin, clopidogrel, and cilostazol might have a beneficial effect on the prevention of atherothrombosis complications following coronary stenting. therefore, we evaluated the safety and efficacy of triple antiplatelet regimen of aspirin, clopidogrel and cilostazol compared with dual antiplatelet regimen of aspirin and clopidogrel in patients with acute coronary syndrome undergoing successful coronary artery stenting. patients undergoing successful coronary stenting were divided into dual antiplatelet therapy (aspirin plus clopidogrel) and triple antiplatelet therapy (aspirin and clopidogrel plus cilostazol) groups. all enrolled patients in triple regimen group will receive cilostazol 100mg, b.i.d., for 6 months in addition to standard dose and duration of aspirin and clopidogrel for post-pci. the primary endpoints included death, myocardial infarction, target lesion revascularization, stent thrombosis within 30 days, binary restenosis at six month and major adverse cardiac events (mace) at one year. the secondary endpoints were side effects of study drugs, including major bleeding, vascular complication, hypersensitivebility, and bleeding complications. the study will be powered to test the hypothesis that triple antiplatelet therapy is better than dual antiplatelet therapy.


Eligibility criteria:
inclusion criteria: * diagnosed with acs undergoing coronary stent implantation * between ages of above 18 years and bellow 80 years. * presence of one or several stenosis in native coronary arteries requiring pci. * willing and able to sign informed consent. exclusion criteria: * a history of bleeding diathesis. * new york heart association functional class iv. * prior pci or coronary bypass grafting \< 3 months. * contraindications to clopidogrel and aspirin (white blood cells counts \< 4×109/l or platelet counts \<100 g.l-1 ;creatinine clearance \<25 ml • min-1 ;active liver disease). * use of glycoprotein iib/iiia inhibitors before pci. * preparing to undergo cabg * taken clopidogrel or cilostazol recently
multimodal neurological monitoring strategy after receiving ecpr

Conditions: Cardiac Arrest

Summary: neurological injury remains an important cause of morbidity and mortality in patients with ecpr. at present, the results of three prospective randomized controlled studies on ecpr are inconsistent, and it is inconclusive whether ecpr can improve the neurological outcomes of patients with refractory cardiac arrest. several study found that extracorporeal membrane oxygenation nonsurvivors can lead toacute brain injury.further research with a systematic neurologic monitoring is necessary to define the timing of acute brain injury in patients with extracorporeal membrane oxygenation.moreover, brain injury that occurs during extracorporeal membrane oxygenation therapy is not easy to detect in time because of the use of analgesics, sedatives, and muscle relaxants. surprisingly, little attention has been paid to the role of cerebral perfusion and oxygenation. moreover,the features of cerebrovascular pathophysiology and optimal management strategies are still vague. therefore multimodal neuromonitoring may be a valuable tool for detecting brain injury in patients with extracorporeal membrane oxygenation and providing early intervention guidance. the aim of this study is to test whether multimodal neuromonitoring will improve 30-day survival with a favorable neurologic outcome in ecpr patients with a refractory ohca.


Eligibility criteria:
inclusion criteria: 1. presumed or known to be 18-75 years old 2. witnessed ohca 3. initially presenting with vf/vt or who have been administered an aed-shock 4. bystander cpr 5. no flow time (time from ca to cpr) was less than 5 min 6. fail to achieve sustained rosc within 15 minutes exclusion criteria: 1. rosc with sustained hemodynamic recovery within 15 minutes 2. terminal heart failure (nyha iii or iv), severe pulmonary disease (copd gold iii or iv), oncological disease, 3. pregnancy 4. bilateral femoral bypass surgery 5. pre arrest cerebral performance category (cpc) score of 3 or 4 6. multiple trauma (injury severity score\>15) 7. estimated that cannulation will start 90 minutes after the initial arrest.

Keywords: multimodality neuromonitoring ecpr out-of-hospital caridac arrest
impact of virtual reality distraction on pain and anxiety for bedside abdominal vac dressing change

Conditions: Pain; Anxiety; Satisfaction, Patient

Summary: we aim to study the use of a virtual reality device (vrd) in addition to our standardized analgesic care protocol for abdominal bedside vac dressing change and we hypothesize to decrease pain and anxiety and to increase patients' comfort by this intervention.

monocentric non-blinded superiority randomized controlled trial: standardized analgesic protocol + virtual reality device vs. standardized analgesic protocol alone for abdominal vac dressing change. the day of the procedure, each patient will receive a standardized local and systemic analgesia 30 minutes before starting the procedure. the referring surgeon will explain at this moment every step of the procedure of bedside abdominal vac dressing change. baseline levels of pain and anxiety will be assessed by use of vas (0-10) and one additional questionnaire (stai). virtual reality device will be activated 15 minutes before the beginning of the procedure and will remain as long as the procedure is going on and for 15minutes after finishing the wound dressing. 15 minutes after removing the vrd and 30minutes after finishing the wound dressing the stai questionnaire and vas for anxiety, pain and satisfaction (0-10) will be completed by the patient.

Eligibility criteria:
inclusion criteria: * patients requiring a bedside abdominal vac dressing change * patients above 18 years old * patients able to give informed consent as documented by signature exclusion criteria: * patients under 18 years old * patients with impaired cognitive status * patients with known psychiatric disorders * patients unable to follow the procedures of the study due to language problems * not consent provided * prior inclusion in the same trial (only 1 vac dressing change per patient can be studied, the first one) * pregnant patients

Keywords: virtual reality pain anxiety satisfaction vac dressing change
a phase 2, 2-stage, 2-cohort study of talazoparib (bmn 673), in locally advanced and/or metastatic breast cancer patients with brca mutation (abrazo study)

Conditions: Breast Neoplasms; BRCA 1 Gene Mutation; BRCA 2 Gene Mutation

Summary: the purpose of this 2-stage, 2-cohort phase 2 trial is to evaluate the safety and efficacy of talazoparib (also known as bmn 673) in subjects with locally advanced or metastatic breast cancer with a deleterious germline brca 1 or brca 2 mutation. subjects will be assigned to either cohort 1 or 2 based on prior chemotherapy for metastatic disease: * cohort 1) subjects with a documented pr or cr to a prior platinum-containing regimen for metastatic disease with disease progression \> 8 weeks following the last dose of platinum; or * cohort 2) subjects who have received \> 2 prior chemotherapy regimens for metastatic disease and who have had no prior platinum therapy for metastatic disease


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed carcinoma of the breast * locally advanced and/or metastatic disease * deleterious or pathogenic germline brca 1 or brca 2 mutation * prior chemotherapy: cohort 1) pr or cr to prior platinum-containing regimen for metastatic disease with disease progression \> 8 weeks following the last dose of platinum; or cohort 2) \> 2 prior chemotherapy regimens for metastatic disease and no prior platinum for metastatic disease * ecog performance status ≤ 1 * have adequate organ function exclusion criteria: * prior enrollment into a clinical trial of a parp inhibitor * cns metastasis except adequately treated brain metastasis documented by baseline ct or mri scan that has not progressed since previous scans and that does not require corticosteroids for management of cns symptoms * prior malignancy except for prior brca-associated cancer as long as there is no current evidence of the prior cancer, carcinoma in situ of the cervix or non-melanoma skin cancer, and a cancer diagnosed and definitively treated \>5 years prior to study enrollment with no subsequent evidence of recurrence * known to be hiv positive, active hepatitis c virus, or active hepatitis b virus * known hypersensitivity to any of the components of talazoparib

Keywords: breast cancer brca mutation parp inhibitor brca 1 brca 2
a study of dcll9718s in participants with relapsed or refractory acute myeloid leukemia (aml) or dcll9718s in combination with azacitidine in participants with previously untreated aml unsuitable for intensive induction chemotherapy

Conditions: Leukemia, Myeloid, Acute

Summary: this phase ia/ib, open-label, multicenter study will evaluate the safety, tolerability, and preliminary efficacy of dcll9718s as a single agent (phase ia, arm a) in participants with relapsed or refractory aml or in combination with azacitidine (phase ib, arm b) in participants with previously untreated aml who are not eligible for intensive induction chemotherapy. each arm will consist of two stages: a dose-escalation stage and an expansion stage. the dose-escalation stage is designed to establish the maximum tolerated dose (mtd) and recommended phase ii dose (rp2d) for dcll9718s alone (arm a) or in combination with azacitidine (arm b). the dose-expansion stage is designed to characterize the long-term safety and tolerability of dcll9718s.


Eligibility criteria:
inclusion criteria: * diagnosis of aml per world health organization (who) criteria (except acute promyelocytic leukemia) * eastern cooperative oncology group (ecog) performance status score of 0, 1, or 2 * adequate end-organ function * willing and able to undergo a pre-treatment bone marrow aspirate and biopsy and subsequent bone marrow aspirates and biopsies during treatment specifically for participants in arm a: * age greater than or equal to (\>/=) 18 years * relapsed or refractory acute myeloid leukemia * participants cannot have received more than two prior regimens specifically for participants in arm b: * treatment-naive participants with aml who are \>/=75 years old * treatment-naive participants unfit for induction chemotherapy for aml due to comorbidities who are \>/=65 years old exclusion criteria: * diagnosis of acute promyelocytc leukemia * prior allogeneic stem cell transplant or solid organ transplant * active central nervous system (cns) involvement by leukemia * history of idiopathic pulmonary fibrosis, organizing pneumonitis (for example \[e.g.\], bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis * treatment with investigational therapy within 14 days prior to cycle 1, day 1 * treatment with a monoclonal antibody within 30 days prior to cycle 1, day 1 * positive for hepatitis c virus (hcv) antibody at screening * active hepatitis b virus (hbv) infection * known positivity for human immunodeficiency virus (hiv) * history of other malignancy within 2 years prior to screening * family history of long qt syndrome, with a qtc interval greater than (\>) 480 millisecond (msec) at screening, or taking concurrent medications known to prolong qt/qtc interval